BioMarin’s New Study on Rapid Drug Desensitization for Palynziq: What Investors Need to Know

Biomarin Pharmaceutical Inc. ((BMRN)) announced an update on their ongoing clinical study.

BioMarin Pharmaceutical Inc. is conducting a Phase 4 clinical study titled ‘A Phase 4 Study to Evaluate the Impact of a Rapid Drug Desensitization (RDD) Protocol for Adults with Phenylketonuria and Experiencing Hypersensitivity Reactions to Palynziq.’ The study aims to assess whether a rapid drug desensitization protocol can enhance drug tolerability and treatment persistence in adult patients with phenylketonuria who experience hypersensitivity reactions to Palynziq, potentially leading to treatment interruptions.

The intervention being tested is a rapid drug desensitization (RDD) to Palynziq, which involves administering gradually increasing doses of the drug over several hours to reach a cumulative dose equal to the reactive dose. This approach is intended to improve patients’ tolerance to Palynziq and maintain their treatment regimen.

This interventional study follows a single-group assignment model with no masking, focusing primarily on treatment. The study is designed to last up to 30 weeks, including a 6-week screening period, a 1-day RDD, and a 24-week follow-up period.

The study began on January 13, 2025, with the primary completion and estimated study completion dates yet to be determined. The latest update was submitted on January 21, 2025, indicating the study’s current recruiting status.

This study update could influence BioMarin’s stock performance by demonstrating the company’s commitment to addressing treatment challenges in phenylketonuria, potentially boosting investor confidence. The outcome of this study may also impact the competitive landscape, as successful results could enhance BioMarin’s position in the market for phenylketonuria treatments.

The study is ongoing, with further details available on the ClinicalTrials portal.